Ontario Drug Benefit Formulary/Comparative Drug Index...2020/12/11 · drug profile on the ODB...

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Ontario Drug Benefit Formulary/Comparative Drug Index

Edition 43

Summary of Changes – December 2020Effective December 18, 2020

Drug Programs Policy and Strategy Branch Drugs and Devices DivisionMinistry of Health

Visit Formulary Downloads: Edition 43

http://www.health.gov.on.ca/en/pro/programs/drugs/edition_43.aspx

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Table of Contents

New Single Source Products ........................................................................................... 3

New Multi-Source Products ........................................................................................... 12

New Off-Formulary Interchangeable (OFI) Products ..................................................... 17

Manufacturer Name Changes ....................................................................................... 19

Product Brand and Manufacturer Name Changes ........................................................ 20

Drug Benefit Price (DBP) Changes ............................................................................... 21

Discontinued Products .................................................................................................. 23

Delisted Products .......................................................................................................... 24

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New Single Source Products DIN/PIN Brand Name Strength Dosage Form Generic

Name Mfr DBP

02496933 Avsola 100mg/ Vial

Pd for Sol-Vial Pk

INFLIXIMAB AMG 493.0000/Vial

Reason For Use Code and Clinical CriteriaCode 592

For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments:

A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR

B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR

C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.)

Maintenance/Renewal:

After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year.

New Single Source Products (Continued)

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For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect.

Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology.

The recommended dosing regimen is 3mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 3mg/kg/dose every 8 weeks up to a maximum of six maintenance doses per year.

LU Authorization Period: 1 year

Code 593

For the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see notes below) with:

I. Age of disease onset less than or equal to 50; AND II. Low back pain and stiffness for greater than 3 months that improves with exercise

and not relieved by rest; AND III. Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal

anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND IV. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than

or equal to 4 for at least 4 weeks while on standard therapy.

Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint.


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After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect.


The recommended dosing regimen is 3 to 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of up to 5mg/kg/dose every 6 to 8 weeks.


Code 594

For the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months.

If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required.


After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect.


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The recommended dosing regimen is 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 5mg/kg/dose every 8 weeks.


Code 595

For the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**.

Claims for the first 6 months must be written by a dermatologist.

Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required.

Patients not responding adequately at 12 weeks should have treatment discontinued.

*Severe plaque psoriasis:

• Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND

• Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND

• Dermatology Life Quality Index (DLQI) score of at least 10.


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**Failure, intolerance or contraindication to adequate trials of standard therapies:

• 6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND

• 12 week trial of phototherapy (unless not accessible), AND • 6 month trial of at least 2 systemic, oral agents used alone or in combination • Methotrexate 15 to 30mg/week • Acitretin (could have been used with phototherapy) • Cyclosporine


After 3 months of therapy, patients who respond to therapy should have:

• At least a 50% reduction in PASI, AND • at least a 50% reduction in BSA involvement, AND • at least a 5 point reduction in DLQI score

The recommended dosing regimen is 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 5mg/kg/dose every 8 weeks.


Code 596

For the treatment of ulcerative colitis disease in patients who meet the following criteria:


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1. Moderate disease

a. Mayo score between 6 and 10 (inclusive) AND b. Endoscopic* subscore of 2 AND c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or

a 1 week course of IV equivalent) OR

d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated)

2. Severe disease

a. Mayo score greater than 10 AND b. Endoscopy* subscore of greater than or equal to 2 AND c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or

1 week IV equivalent) OR

d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated)

*The endoscopy procedure must be done within the 12 months prior to initiation of treatment.

The recommended dosing regimen for induction is 5mg/kg/dose at 0, 2 and 6 weeks followed by 5mg/kg/dose every 8 weeks.


Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained at Mayo score less than 6 AND who demonstrate at least 50% reduction in the dose of prednisone compared with the starting dose following the first 6 months of treatment with Avsola or be off corticosteroids after the first year of treatment.


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The recommended dosing regimen is 5mg/kg/dose every 8 weeks.


Code 597

For the treatment of moderate to severe (luminal) Crohn's Disease in patients who meet the following criteria:

• HBI (Harvey Bradshaw Index) score greater than or equal to 7; AND • Failed to respond to conventional treatment with a corticosteroid equivalent to a

daily dose of prednisone 40mg daily for at least 2 weeks OR

• the patient is stabilized on corticosteroid but cannot be tapered to a corticosteroid dose below prednisone 20mg daily or equivalent; AND

• Failed to respond to an immunosuppressive agent (azathioprine, 6-mercaptopurine, methotrexate, or cyclosporine) tried for at least 3 months (or where the use of immunosuppressants is contraindicated).

The recommended dosing regimen is 5mg/kg/dose at 0, 2 and 6 weeks followed by 5mg/kg/dose every 8 weeks. (Note: Higher doses up to 10mg/kg/dose may be considered in patients who have failed to respond to lower doses).


Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained with a 50% reduction in the Harvey Bradshaw Index (HBI) from pre-treatment measurement, AND improvement of symptoms (For example: absence of bloody diarrhea, weight is stable or increased), AND the use of corticosteroids and/or other immunosuppressive therapy is reduced, being tapered, or discontinued.


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For funding beyond the second year, the patient must continue to demonstrate benefit and if unable to be discontinued on corticosteroids, the physician may wish to consider other funded alternatives.


Code 598

For the treatment of fistulizing Crohn's Disease in patients with actively draining perianal or enterocutaneous fistula(e) who meet the following criteria:

• Fistula has persisted despite a course of antibiotic therapy (ciprofloxacin and/or metronidazole) and immunosuppressive therapy (azathioprine or 6-mercaptopurine).

The recommended dosing regimen is 5mg/kg/dose at 0, 2 and 6 weeks followed by 5mg/kg/dose every 8 weeks. (Note: Higher doses up to 10mg/kg/dose may be considered in patients who have failed to respond to lower doses.)


Maintenance therapy is funded for patients who meet the Ministry initiation criteria for fistulizing Crohn's disease and who have demonstrated benefit from treatment (e.g. partial resolution of fistulae and symptom improvement.) The recommended dosing regimen is 5mg/kg/dose every 8 weeks.



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DIN/PIN Brand Name Strength Dosage Form Generic Name Mfr DBP 02469901 Admelog 100U/mL Inj Sol-10mL

Vial Pk INSULIN LISPRO

SAC 22.7000/Vial

02469898 Admelog 100U/mL Inj Sol-5x3mL Cart Pk

INSULIN LISRO

SAC 45.0000

02469871 Admelog 100U/mL Inj Sol-5x3mL SoloSTAR Pref Pen Pk

INSULIN LISPRO

SAC 45.0000

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New Multi-Source Products Where applicable, please consult the respective brand reference product’s drug profile on the ODB e-Formulary for the details of the Limited Use (LU) code and criteria, and/or any associated Therapeutic Notes (TN).

DIN/PIN Product Name Strength Dosage Form Mfr DBP 02477726 AG-Amoxicillin 500mg Cap ANG 0.1308

(Interchangeable with Amoxil – GB)

DIN/PIN Product Name Strength Dosage Form Mfr DBP 02369184 AG-Atenolol 50mg Tab ANG 0.1107 02369192 AG-Atenolol 100mg Tab ANG 0.1821

(Interchangeable with Tenormin – GB)

DIN/PIN Product Name Strength Dosage Form Mfr DBP 02476142 AG-Pravastatin 10mg Tab ANG 0.2916 02476150 AG-Pravastatin 20mg Tab ANG 0.3440 02476169 AG-Pravastatin 40mg Tab ANG 0.4143

(Interchangeable with Pravachol – GB)

DIN/PIN Product Name Strength Dosage Form Mfr DBP 02475979 AG-Quetiapine 25mg Tab ANG 0.0494

(Interchangeable with Seroquel – GB)

New Multi-Source Products (Continued)

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DIN/PIN Product Name Strength Dosage Form Mfr DBP 02477882 AG-Sertraline 25mg Cap ANG 0.1516 02477890 AG-Sertraline 50mg Cap ANG 0.3032 02477904 AG-Sertraline 100mg Cap ANG 0.3303

(Interchangeable with Zoloft – GB)

DIN/PIN Product Name Strength Dosage Form Mfr DBP 02475936 AG-Topiramate 25mg Tab ANG 0.2433 02475944 AG-Topiramate 100mg Tab ANG 0.4583

(Interchangeable with Topamax – GB)

DIN/PIN Product Name Strength Dosage Form Mfr DBP 02460750 GLN-Ezetimibe 10mg Tab GLP 0.1811

(Interchangeable with Ezetrol – LU)

DIN/PIN Product Name Strength Dosage Form Mfr DBP 02469812 GLN-Olmesartan 20mg Tab GLP 0.3019 02469820 GLN-Olmesartan 40mg Tab GLP 0.3019

(Interchangeable with Olmetec – GB)

DIN/PIN Product Name Strength Dosage Form Mfr DBP 02472686 Jamp Granisetron 1mg Tab JPC 4.5000

(Interchangeable with Kytril – LU)


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DIN/PIN Product Name Strength Dosage Form Mfr DBP 02499258 NRA-Olmesartan 20mg Tab NRA 0.3019 02499266 NRA-Olmesartan 40mg Tab NRA 0.3019

(Interchangeable with Olmetec – GB)

DIN/PIN Product Name Strength Dosage Form Mfr DBP 02287021 Baclofen 10mg Tab SAI 0.1595

(Interchangeable with Lioresal – GB)

DIN/PIN Product Name Strength Dosage Form Mfr DBP 02287048 Baclofen 20mg Tab SAI 0.3104

(Interchangeable with Lioresal DS – GB)

DIN/PIN Product Name Strength Dosage Form Mfr DBP 02401509 Amoxicillin 500mg Cap SIV 0.1308

(Interchangeable with Amoxil – GB)

DIN/PIN Product Name Strength Dosage Form Mfr DBP 02495562 Bisoprolol Tablets 5mg Tab SIV 0.0715 02495570 Bisoprolol Tablets 10mg Tab SIV 0.1044

(Interchangeable with Monocor – GB)


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DIN/PIN Product Name Strength Dosage Form Mfr DBP 02495651 Cephalexin 500mg Tab SIV 0.1731

(Interchangeable with Keflex – GB)

DIN/PIN Product Name Strength Dosage Form Mfr DBP 02496674 Mirtazapine 30mg Tab SIV 0.3100

(Interchangeable with Remeron – GB)

DIN/PIN Product Name Strength Dosage Form Mfr DBP 02343665 Olanzapine ODT 5mg ODT SIV 0.3574 02343673 Olanzapine ODT 10mg ODT SIV 0.7143 02343681 Olanzapine ODT 15mg ODT SIV 1.0711

(Interchangeable with Zyprexa Zydis – GB)

DIN/PIN Product Name Strength Dosage Form Mfr DBP 02388235 Paroxetine 20mg Tab SIV 0.3250 02388243 Paroxetine 30mg Tab SIV 0.3453

(Interchangeable with Paxil – GB)

DIN/PIN Product Name Strength Dosage Form Mfr DBP 02389703 Pravastatin 10mg Tab SIV 0.2916 02389738 Pravastatin 20mg Tab SIV 0.3440 02389746 Pravastatin 40mg Tab SIV 0.4143

(Interchangeable with Pravachol – GB)


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DIN/PIN Product Name Strength Dosage Form Mfr DBP 02308363 Ramipril 1.25mg Cap SIV 0.0708 02287927 Ramipril 2.5mg Cap SIV 0.0817 02287935 Ramipril 5mg Cap SIV 0.0817 02287943 Ramipril 10mg Cap SIV 0.1034

(Interchangeable with Altace – GB)

DIN/PIN Product Name Strength Dosage Form Mfr DBP 02390302 Telmisartan HCTZ 80mg &

12.5mg Tab SIV 0.2098

02390310 Telmisartan HCTZ 80mg & 25mg

Tab SIV 0.2098

(Interchangeable with Micardis Plus – GB)

DIN/PIN Product Name Strength Dosage Form

Mfr DBP

02481901 0.3% w/v & 0.1% w/v

TAR 21.6300 Taro-Ciprofloxacin/Dexamethasone

Otic Susp-7.5mL Pk (With Preservative)

(Interchangeable with Ciprodex – LU)

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New Off-Formulary Interchangeable (OFI) Products DIN/PIN Brand Name Strength Dosage Form Mfr DBP 02485419 AG-Cyclobenzaprine 10mg Tab ANG 0.3765

(Interchangeable with Flexeril)

DIN/PIN Brand Name Strength Dosage Form Mfr DBP 02405059 Auro-Valacyclovir 1000mg Tab AUR 5.8537

(Interchangeable with Valtrex)

DIN/PIN Brand Name Strength Dosage Form Mfr DBP 02492911 Sandoz Everolimus 2.5mg Tab SDZ 172.2559 02492938 Sandoz Everolimus 5mg Tab SDZ 172.2559 02492946 Sandoz Everolimus 10mg Tab SDZ 172.2559

(Interchangeable with Afinitor)

DIN/PIN Brand Name Strength Dosage Form Mfr DBP 02343703 Olanzapine ODT 20mg ODT SIV 7.5977

(Interchangeable with Zyprexa Zydis)

New Off-Formulary Interchangeable (OFI) Products (Continued)

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DIN/PIN Brand Name Strength Dosage Form Mfr DBP 02388227 Paroxetine 10mg Tab SIV 1.0430

(Interchangeable with Paxil)

DIN/PIN Brand Name Strength Dosage Form Mfr DBP 02506203 Taro-Clobetasol

Shampoo 0.05% w/w Top Shampoo TAR 1.0838/mL

(Interchangeable with Clobex Shampoo)

DIN/PIN Brand Name Strength Dosage Form Mfr DBP 02482398 Taro-Fampridine 10mg ER Tab TAR 8.4730

(Interchangeable with Fampyra)

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Manufacturer Name Changes DIN/PIN Brand Name Strength Dosage Form Current Mfr New Mfr 00511528* Mogadon 5mg Tab VAL AAP 00511536* Mogadon 10mg Tab VAL AAP

* These 2 DINs, along with Winpred 1mg Tab (DIN 00271373), are not discontinued asannounced in the November 2020 update.

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Product Brand and Manufacturer Name Changes DIN/PIN Current Brand

Name Current Mfr

New Brand Name

New Mfr

Strength Dosage Form

00771376 Apo-Diltiaz APX AA-Diltiaz AAP 30mg Tab 00771384 Apo-Diltiaz APX AA-Diltiaz AAP 60mg Tab 02243180 Apo-Feno-Micro APX AA-Feno-

Micro AAP 67mg Cap

02239864 Apo-Feno-Micro APX AA-Feno-Micro

AAP 200mg Cap

00521698 Apo-Flurazepam APX Flurazepam AAP 15mg Cap 00521701 Apo-Flurazepam APX Flurazepam AAP 30mg Cap 02238560 Apo-Flutamide APX Flutamide AAP 250mg Tab 02272873 Apo-Levocarb CR APX AA-Levocarb

CR AAP 100mg &

25mg CR Tab

02245211 Apo-Levocarb CR APX AA-Levocarb CR

AAP 200mg & 50mg

CR Tab

02084090 Apo-Minocycline APX Minocycline AAP 50mg Cap 02084104 Apo-Minocycline APX Minocycline AAP 100mg Cap 02259893 Apo-Tizanidine APX Tizanidine AAP 4mg Tab

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Drug Benefit Price (DBP) Changes DIN/PIN Brand Name Strength Dosage

Form Mfr DBP

02266695 Lithmax 300mg ER Tab AAP 0.2753 02239698 Apo-Divalproex 125mg Ent Tab APX 0.1539 02239699 Apo-Divalproex 250mg Ent Tab APX 0.2767 02239700 Apo-Divalproex 500mg Ent Tab APX 0.5537 02308894 Apo-Granisetron 1mg Tab APX 4.5000 02299801 Auro-Mirtazapine OD 15mg ODT AUR 0.4046 02299828 Auro-Mirtazapine OD 30mg ODT AUR 0.8087 02299836 Auro-Mirtazapine OD 45mg ODT AUR 1.2132 02247162 Crestor 10mg Tab AZC 1.4033 01978918 Pulmicort Nebuamp 0.25mg/mL Inh Susp AZC 0.4790 01978926 Pulmicort Nebuamp 0.5mg/mL Inh Susp AZC 0.9558 02244126 Dovobet 50mcg/g &

0.5mg/g Oint LEO 1.6726

01976133 Dovonex 50mcg/g Oint LEO 0.9531 02270811 Finacea 15% Top Gel LEO 0.6688 00586668 Fucidin 2% Cr LEO 0.8547 00586676 Fucidin 2% Oint LEO 0.8547 09857367 Innohep 2500IU/0.25mL Inj Pref Syr LEO 5.8080 02358158 Innohep 3500IU/0.35mL Inj Pref Syr LEO 8.1220 02358166 Innohep 4500IU/0.45mL Inj Pref Syr LEO 10.4460 02231478 Innohep 10000IU/0.5mL Inj Pref Syr LEO 23.6900 02429470 Innohep 12000IU/0.6mL Inj Pref Syr LEO 28.4540 02358174 Innohep 14000IU/0.7mL Inj Pref Syr LEO 33.1960 02429489 Innohep 16000IU/0.8mL Inj Pref Syr LEO 37.9390 02358182 Innohep 18000IU/0.9mL Inj Pref Syr LEO 42.6760 02229515 Innohep 20000IU/mL Inj-2mL Pk LEO 93.5300 02244149 Protopic 0.03% Oint LEO 2.6173 02244148 Protopic 0.1% Oint LEO 2.8000 02458926 Mylan-Divalproex 125mg Ent Tab MYL 0.1539 02458934 Mylan-Divalproex 250mg Ent Tab MYL 0.2767 02459019 Mylan-Divalproex 500mg Ent Tab MYL 0.5537

Drug Benefit Price (DBP) Changes (Continued)

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DIN/PIN Brand Name Strength Dosage Form Mfr DBP 02452359 Nat-Granisetron 1mg Tab NAT 4.5000 80003615 Erdol 8288IU/mL O/L ODN 0.3325/mL 02449439 Ran-Ramipril HCTZ 2.5mg &

12.5mg Tab RAN 0.2242

02449447 Ran-Ramipril HCTZ 5mg & 12.5mg

Tab RAN 0.3016

02231800 Sab-Indomethacin 100mg Sup SDZ 1.2033 02390701 Sandoz Fenofibrate E 145mg Tab SDZ 0.8233 02244403 Taro-Carbamazepine 100mg Chew Tab TAR 0.1702 02244404 Taro-Carbamazepine 200mg Chew Tab TAR 0.3302

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Discontinued Products (Some products will remain on Formulary for six months to facilitate depletion of supply)

DIN/PIN Brand Name Strength Dosage Form Mfr 00545023 Apo-Bisacodyl 5mg Ent Tab APX 02279320 Invirase 500mg Tab HLR

Mogadon 5mg (DIN 00511528) and 10mg (00511536) Tablets and Winpred 1mg Tablets (DIN 00271373) are not discontinued as announced in the November 2020 Formulary update and continue to be funded on the Formulary. For further details, please see the notes in the Manufacturer Name Changes section.

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Delisted Products DIN/PIN Brand Name Strength Dosage Form Mfr 09858123* Phenelzine Sulfate

Tablets USP 15mg Tab LUP

02465167 Mint-Fenofibrate E 145mg Tab MIN 02239701 Teva-Divalproex 125mg Ent Tab TEV 02239702 Teva-Divalproex 250mg Ent Tab TEV 02239703 Teva-Divalproex 500mg Ent Tab TEV

* This product is removed as a temporary benefit as the manufacturer is unable toprovide supply. Prescribers, pharmacists and consumers are asked to refer to noticesprovided by Erfa Canada (manufacturer of Nardil) and Health Canada for additionalinformation regarding the shortage of phenelzine sulfate.

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